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A Study to Evaluate Use of Induced Skin Blisters in Adult Participants With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Participants

Primary Purpose

Dermatitis, Atopic, Asthma, Healthy

Status
Completed
Phase
Early Phase 1
Locations
International
Study Type
Interventional
Intervention
Allergic Skin Reaction (ASR) Testing and Skin Blister Induction
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Atopic Dermatitis, Asthma, Healthy, Skin Blisters, Adult Participants

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant must have signed an informed consent document prior to any study related procedures indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

  • Participant must be willing/able to adhere to the study visit schedule and other requirements, prohibitions and restrictions specified in this protocol

    * For participants with Asthma:

  • Participant must have a physician documented diagnosis of asthma for at least 12 months before Screening

  • Participant must have an Asthma Control Questionnaire 6 (ACQ6) less than (<) 1.5 at Screening

    * For participants with Atopic Dermatitis:

  • Participant must have a physician documented diagnosis of atopic dermatitis for at least 12 months before Screening based on UK refinement of the Hanifin and Rajka's diagnostic criteria
  • Participant must have atopic dermatitis with and Investigators Global Assessment (IGA) score of 2 to 4 at Screening

Exclusion Criteria:

  • Participant has taken any prohibited or restricted medications as noted below under Prestudy and Concomitant Therapy

  • Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 6 weeks or 5 half-lives (whichever is longer) before the Screening visit

    * For participants with Asthma:

  • Participant has a history of life-threatening asthma, defined as a history of respiratory arrest or requiring intubation for asthma

  • Participant had been admitted to a hospital for asthma in the 1 year before Screening

    * For participants with Atopic Dermatitis:

  • Participant has evidence of any other skin condition that would interfere with assessment of Atopic Dermatitis (AD)
  • Participant has active AD related infection or has had an active AD infection within 2 weeks of Screening (participants with evidence of colonization on skin swab testing but with no infection are allowed)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy + Atopic Dermatitis + Allergic Asthmatic Participants

Arm Description

Healthy participants will be enrolled in order to allow for training on the overall skin blister induction and fluid aspiration process. Participants with atopic dermatitis (AD) or allergic asthma (AA) will be observed for the use of induced skin blisters after allergic skin reaction (ASR).

Outcomes

Primary Outcome Measures

Cell Concentration in Suction Skin Blister Fluid After Allergic Skin Reaction (ASR) Induction with D. Pteronyssinus (House Dust Mite [HDM]), Alternaria alternata, or Aspergillus fumigatus Allergens
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and messenger RNA (mRNA) analysis.
Cell Concentration in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and mRNA analysis.
Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
The remaining fluid from aspirated skin blister fluid after separated and processed for cell population analysis will be assessed for inflammatory mediator responses. Inflammatory cytokines and other soluble mediators in blister fluid will be measured by immunoassay.
Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
The remaining fluid from aspirated skin blister fluid after separated and processed for cell population analysis will be assessed for inflammatory mediator responses. Inflammatory cytokines and other soluble mediators in blister fluid will be measured by immunoassay.

Secondary Outcome Measures

Success Percentage of Repeated Skin Blister Induction and Blister Fluid Aspiration
Success percentage for blister induction will be defined as number of blisters formed with recovery of at least 200 microliter (μL) of blister fluid, divided by the total blisters induced.
Cell Concentration in Suction Skin Blister Fluid After ASR Induction with Non-protease Allergens
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and mRNA analysis.
Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with Non-protease Allergens
The remaining fluid from aspirated skin blister fluid after separated and processed for cell population analysis will be assessed for inflammatory mediator responses. Inflammatory cytokines and other soluble mediators in blister fluid will be measured by immunoassay.

Full Information

First Posted
January 16, 2015
Last Updated
October 2, 2015
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02343783
Brief Title
A Study to Evaluate Use of Induced Skin Blisters in Adult Participants With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Participants
Official Title
A Phase 0 Study Exploring the Use of Induced Skin Blisters in Adult Subjects With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to characterize the cell (the basic building block of all living things) populations and inflammatory (pain and swelling) mediator responses in suction skin blister fluid after allergic skin reaction (ASR) [rash] induction with D. Pteronyssinus [house dust mite (HDM)], Alternaria alternata, or Aspergillus fumigatus allergens in participants with atopic dermatitis (AD) [Skin rash, Eczema] or allergic asthma (AA) [breathing disorder in which there is a wheezing and difficulty breathing].
Detailed Description
This is an interventional (a treatment given during the course of a research study) and multicenter (when more than one hospital or medical school team work on a medical research study) study. The study will consist of 3 Phases: Screening Phase (Up to 4 weeks), Data Collection Phase (9 days) and, Follow-up Phase (7 days). The maximum study duration for each participant will not exceed 43 days. Primarily, the cell populations and inflammatory mediator responses in suction skin blister fluid after allergic skin reaction (ASR) will be assessed. Participants' safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic, Asthma, Healthy
Keywords
Atopic Dermatitis, Asthma, Healthy, Skin Blisters, Adult Participants

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy + Atopic Dermatitis + Allergic Asthmatic Participants
Arm Type
Experimental
Arm Description
Healthy participants will be enrolled in order to allow for training on the overall skin blister induction and fluid aspiration process. Participants with atopic dermatitis (AD) or allergic asthma (AA) will be observed for the use of induced skin blisters after allergic skin reaction (ASR).
Intervention Type
Other
Intervention Name(s)
Allergic Skin Reaction (ASR) Testing and Skin Blister Induction
Intervention Description
Participants will not receive any intervention in this study. Healthy participants will be enrolled in order to allow for training on the overall skin blister induction and fluid aspiration process. The cell populations and inflammatory mediator responses in suction skin blister fluid after allergic skin reaction (ASR) in participants with atopic dermatitis (AD) or allergic asthma (AA) will be observed.
Primary Outcome Measure Information:
Title
Cell Concentration in Suction Skin Blister Fluid After Allergic Skin Reaction (ASR) Induction with D. Pteronyssinus (House Dust Mite [HDM]), Alternaria alternata, or Aspergillus fumigatus Allergens
Description
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and messenger RNA (mRNA) analysis.
Time Frame
Hour 4 after the end of the blister induction
Title
Cell Concentration in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
Description
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and mRNA analysis.
Time Frame
Hour 24 after the end of the blister induction
Title
Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
Description
The remaining fluid from aspirated skin blister fluid after separated and processed for cell population analysis will be assessed for inflammatory mediator responses. Inflammatory cytokines and other soluble mediators in blister fluid will be measured by immunoassay.
Time Frame
Hour 4 after the end of the blister induction
Title
Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
Description
The remaining fluid from aspirated skin blister fluid after separated and processed for cell population analysis will be assessed for inflammatory mediator responses. Inflammatory cytokines and other soluble mediators in blister fluid will be measured by immunoassay.
Time Frame
Hour 24 after the end of the blister induction
Secondary Outcome Measure Information:
Title
Success Percentage of Repeated Skin Blister Induction and Blister Fluid Aspiration
Description
Success percentage for blister induction will be defined as number of blisters formed with recovery of at least 200 microliter (μL) of blister fluid, divided by the total blisters induced.
Time Frame
Day 1 and 8
Title
Cell Concentration in Suction Skin Blister Fluid After ASR Induction with Non-protease Allergens
Description
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and mRNA analysis.
Time Frame
4 and 24 Hours after the end of the blister induction
Title
Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with Non-protease Allergens
Description
The remaining fluid from aspirated skin blister fluid after separated and processed for cell population analysis will be assessed for inflammatory mediator responses. Inflammatory cytokines and other soluble mediators in blister fluid will be measured by immunoassay.
Time Frame
4 and 24 Hours after the end of the blister induction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant must have signed an informed consent document prior to any study related procedures indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Participant must be willing/able to adhere to the study visit schedule and other requirements, prohibitions and restrictions specified in this protocol * For participants with Asthma: Participant must have a physician documented diagnosis of asthma for at least 12 months before Screening Participant must have an Asthma Control Questionnaire 6 (ACQ6) less than (<) 1.5 at Screening * For participants with Atopic Dermatitis: Participant must have a physician documented diagnosis of atopic dermatitis for at least 12 months before Screening based on UK refinement of the Hanifin and Rajka's diagnostic criteria Participant must have atopic dermatitis with and Investigators Global Assessment (IGA) score of 2 to 4 at Screening Exclusion Criteria: Participant has taken any prohibited or restricted medications as noted below under Prestudy and Concomitant Therapy Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 6 weeks or 5 half-lives (whichever is longer) before the Screening visit * For participants with Asthma: Participant has a history of life-threatening asthma, defined as a history of respiratory arrest or requiring intubation for asthma Participant had been admitted to a hospital for asthma in the 1 year before Screening * For participants with Atopic Dermatitis: Participant has evidence of any other skin condition that would interfere with assessment of Atopic Dermatitis (AD) Participant has active AD related infection or has had an active AD infection within 2 weeks of Screening (participants with evidence of colonization on skin swab testing but with no infection are allowed)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Antwerp
Country
Belgium
City
Merksem
Country
Belgium
City
Berlin
Country
Germany
City
Hamburg
Country
Germany
City
Hannover
Country
Germany
City
Kiel
Country
Germany
City
Mönchengladbach
Country
Germany

12. IPD Sharing Statement

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A Study to Evaluate Use of Induced Skin Blisters in Adult Participants With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Participants

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